Class 2 Device Recall Pentax

• Date Initiated by Firm: April 06, 2016
• Date Posted: July 23, 2016
• Recall Status: Terminated on July 17, 2017
• Recall Number: Z-2277-2016
• Recall Event ID: 73985
• 510(K)Number: K963056
• Product Classification: duodenoscope and accessories, flexible/rigid - Product Code FDT
• Product: Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
• Code Information: Model #'s FD-34V and ED-3490TK
• Recalling Firm/ Manufacturer: Pentax Medical Company; 3 Paragon Dr; Montvale NJ 07645-1782
• For Additional Information Contact: Mr. Paul Silva; 800-431-5880 Ext. 2064
• Manufacturer Reason for Recall: Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
• FDA Determined Cause: Device Design
• Action: Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: recall.coordinator@pentaxmedical.com.
• Quantity in Commerce: 433 units
• Distribution: US Nationwide Distribution
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FDT